MYBULEN Capsule Ref.[51175] Active ingredients: Codeine Ibuprofen Paracetamol

Source: Health Products Regulatory Authority (ZA)  Revision Year: 2022  Publisher: PHARMACARE LIMITED, Healthcare Park, Woodlands Drive, Woodmead, 2191

5.1. Pharmacodynamic properties

Category and Class: A 2.8 Analgesic combinations
Pharmacotherapeutic group: Codeine and other non-opioid analgesics
ATC code: N02AJ09

Mechanism of action

MYBULEN CAPSULES have an analgesic, anti-inflammatory and antipyretic action.

Ibuprofen has analgesic, antipyretic and anti-inflammatory activities. Ibuprofen exerts its anti-inflammatory action peripherally in inflamed tissue by reducing prostaglandin activity and by inhibiting synthesis and/or actions of other local mediators of the inflammatory response.

Paracetamol has analgesic and antipyretic effects.

Codeine is metabolised to morphine, which in turn, exerts an analgesic effect.

5.2. Pharmacokinetic properties

Absorption

Ibuprofen

Ibuprofen is rapidly absorbed from the gastrointestinal tract after oral administration.

Paracetamol

Absorption following oral administration is rapid and almost complete.

Codeine phosphate

Codeine is readily absorbed from the gastrointestinal tract

Distribution

Ibuprofen

The half-life of ibuprofen is about 2 hours.

Paracetamol

Paracetamol has a half-life of 1 to 3 hours and time to peak concentration of 0,5 to 2 hours.

Codeine phosphate

Its half-life is 2,5 to 4 hours. The time to peak effect is 1 to 2 hours.

Biotransformation

Paracetamol

Paracetamol is metabolised in the liver primarily by conjugation.

Codeine phosphate

Codeine is metabolised in the liver. The cytochrome P450 enzyme 2D6 converts codeine to morphine, one of its metabolites. About 10% of the dose is demethylated to morphine. Onset of action is 30 to 45 minutes.

Elimination

Ibuprofen

More than 90% of an ingested dose is excreted in the urine as metabolites or their conjugates.

Paracetamol

Paracetamol is renally excreted primarily as metabolites, and about 3% of a dose may be excreted unchanged.

Codeine phosphate

Codeine is eliminated via the kidneys.

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